Immunoadsorption apheresis (Selesorb Ó ) in the treatment of chronic hepatitis C virus-related type 2 mixed cryoglobulinemia C. Stefanutti a, * ,S.DiGiacomo a , M. Mareri a ,F.DeLorenzo a , G.DÕAlessandri b , F. Angelico a ,A.Bucci a ,A.Musca a , A. Mammarella a a Dipartimento di Clinica e Terapia Medica Applicata, Plasmapheresis Unit, University ÔLa Sapienza’ of Rome, ÔUmberto I’ Hospital, Viale del Policlinico, 155, 00161 Rome, Italy b Immunohematology, Azienda U.S.L., 3 Pistoia, Italy Received 2 September 2002; received in revised form 22 October 2002; accepted 2 November 2002 Abstract In this short-term open label clinical pilot study, conducted at one center, the immune complex dextran sulphate adsorber(Selesorb Ó )wasusedtotreatfourfemalepatientsaged59–69withHCV-relatedcryoglobulinaemia,vasculitis and/orneuropathy.Theprimarytrialobjectivewastoassesstheclinicalefficacyoftheimmunoadsorber.Thesecondary objectiveofthetrialwastodeterminethesafetyoftheadsorberandtoinvestigatetheadsorptioncapacity,measuredas the adsorption of cryoglobulin-related immune complexes and the resulting influence on plasma components of the immune system. The patients have been submitted to treatment with the immunoadsorber, at approximately 1–3 days intervals, completing sixsessions.Thefollow-upwasonemonth.InthepatientstreatedwithSelesorb Ó ,weobserveda statisticallysignificantdecreaseinplasmaofallclassesofimmunoglobulins(IgA:5–28%;IgG:14–44%;IgM:8–38%).In twopatientswithperipheralneuropathysecondarytocryoglobulinemia,thesymptomatologywasimproved.Inathird patienttheneurologicalinvolvementwassubstantiallyunchanged,andthesameunsuccessfuloutcomewasobservedfor Sj€ ogren syndrome is concerned. Nevertheless, the two patients with lower extremity vasculitis showed an appreciable improvement.Wefailedtoobservesignificantsideeffectsdirectlyrelatedtotheuseofthisimmunoadsorbent. Ó 2003ElsevierScienceLtd.Allrightsreserved. 1. Background Chronic hepatitis C virus (HCV) infection is frequently associated with autoimmune phenom- ena[1].Mixedcryoglobulinemia(MC)candevelop inmorethan50%ofchronicHCV-infectedpatients [2]. Approximately, one third of patients with HCV-associated MC will develop autoimmune symptoms [3,4]. The strong association between HCVinfectionandMCsuggeststhepossibilitythat HCVplaysamajorroleintheproductionofMC with following complications: peripheral neuropa- thy, Sj€ ogren syndrome, rash, myositis, lower ex- tremity vasculitis [5–7]. Pulse cyclophosphamide therapymayoftennotbesufficienttocontrolsevere www.elsevier.com/locate/transci Transfusion and Apheresis Science 28 (2003) 207–214 * Corresponding author. Tel.: +39-06-499-70-578; fax: +39- 06-444-02-90. E-mail addresses: plasmaferesi@tin.it, c.incas@flashnet.it (C. Stefanutti). URL: http://w3.uniroma1.it/plasmapheresis. 1473-0502/03/$ - see front matter Ó 2003 Elsevier Science Ltd. All rights reserved. doi:10.1016/S1473-0502(03)00055-7